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Relmada Therapeutics Reports Second Quarter 2026 Financial Results and Provides Business Update

On August 6, 2026 Relmada Therapeutics, Inc. (Nasdaq: RLMD, "Relmada" or the "Company"), a clinical-stage biotechnology company advancing innovative therapies for oncology and central nervous system disorders, reported financial results for the second quarter ended June 30, 2026, and provided a business update.

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"Relmada has entered a critical execution phase as we prepare NDV-01 for registrational development. With FDA alignment, a robust clinical dataset, an experienced leadership team, and capital expected to fund operations through completion of the Phase 3 RESCUE program, we believe the Company is well positioned to create significant long-term value," said Sergio Traversa, Chief Executive Officer of Relmada Therapeutics. "Our immediate priority is manufacturing execution for NDV-01. Bringing a novel, sustained-release therapy of this kind into registrational development requires careful execution, and we are focused on completing the remaining activities needed to support the IND filing."

Manufacturing and CMC Update

The Company is advancing manufacturing and chemistry, manufacturing, and controls (CMC) activities to support planned IND filings for both NDV-01 and sepranolone by year-end 2026. Each program is progressing along its own development path.

NDV-01: Manufacturing and CMC activities supporting the planned NDV-01 IND submission are ongoing. The Company expects to submit the NDV-01 IND by year-end 2026 and initiate the Phase 3 RESCUE registrational program upon IND clearance. Clinical trial sites are engaged and prepared to begin enrollment following IND clearance.

Sepranolone: Formulation development for sepranolone is complete, and the Company is finalizing the pre-filled syringe delivery system. This is the remaining step ahead of the sepranolone IND submission, which is expected by year-end 2026. The company expects to initiate the Phase 2 proof-of-concept study in Prader-Willi Syndrome following IND clearance.

Corporate Update

During the quarter, Relmada strengthened its leadership team with the appointment of Bipin Dalmia, PhD, MBA, as Chief Business Officer. He brings nearly three decades of biopharmaceutical leadership experience spanning business development, portfolio strategy, commercial planning, and uro-oncology, including leadership of the U.S. launch, indication expansion, global commercialization, and long-term manufacturing strategy for the first FDA-approved intravesical gene therapy for NMIBC.

"Since joining Relmada, I have become increasingly convinced that NDV-01 represents one of the most compelling opportunities in NMIBC," said Bipin Dalmia, Chief Business Officer of Relmada Therapeutics. "As the NMIBC treatment landscape continues to evolve, patients and physicians are seeking therapies that deliver meaningful efficacy and durability without compromising convenience, tolerability, or ease of use. As we advance toward registrational development, NDV-01’s highly differentiated profile and potential applicability across multiple patient populations position it to become a foundational and best-in-class intravesical therapy across the NMIBC disease spectrum."

Expected Upcoming Relmada Milestones:

NDV-01:

NDV-01 United States IND filing – By YE26
NDV-01 Phase 3 RESCUE program initiation – Upon IND Clearance
Sepranolone:

Sepranolone United States IND filing – By YE26
Sepranolone Phase 2 initiation in Prader-Willi Syndrome – Upon IND Clearance
Financial Results

Second Quarter 2026 Financial Results

Research and development expense for the three months ended June 30, 2026, totaled $8.4 million, compared to $2.8 million for the three months ended June 30, 2025, an increase of $5.6 million. The increase was primarily attributable to higher NDV-01 and sepranolone study costs and increased manufacturing and drug storage costs, partially offset by lower employee compensation.
General and administrative expense for the three months ended June 30, 2026, totaled $6.6 million compared to $7.4 million for the three months ended June 30, 2025, a decrease of approximately $0.8 million. The decrease was primarily driven by lower stock-based compensation and lower employee compensation, partially offset by higher stock appreciation rights expense and consulting services.
Net cash used in operating activities for the three months ended June 30, 2026, totaled $9.6 million compared to $6.4 million for the three months ended June 30, 2025.
The net loss for the three months ended June 30, 2026, was $12.9 million, or $0.11 per basic and diluted share, compared with a net loss of $9.9 million, or $0.30 per basic and diluted share, for the three months ended June 30, 2025.
As of June 30, 2026, the Company’s cash, cash equivalents, and short-term investments balance were $217.7 million, compared to cash, cash equivalents, and short-term investments of approximately $93.0 million at December 31, 2025.
The Company’s current cash, cash equivalents, and short-term investments as of June 30, 2026, are expected to provide sufficient resources to fund Company operations through 2029, including completion of the Phase 3 NDV-01 RESCUE program.
The Company had 106,669,846 shares outstanding, as of August 4, 2026
Conference Call and Webcast Information:
Relmada will host a conference call and webcast today at 4:30 PM ET to discuss recent business progress and financial results.

(Press release, Relmada Therapeutics, AUG 6, 2026, View Source [SID1234669840])

CytomX Therapeutics Announces Q2 2026 Financial Results and Provides Business Update

On August 6, 2026 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of masked, conditionally activated biologics, reported Q2 2026 financial results and provided a business update.

"CytomX had a productive second quarter as we advanced and broadened the Varseta-M program, the only EpCAM-directed antibody drug conjugate (ADC) in clinical development and a potentially best-in-class ADC for colorectal cancer. As we drive Varseta-M towards its first registrational study in late-line CRC, we are also accelerating our broader vision of earlier line utilization in CRC combination regimens, while also initiating development in additional gastrointestinal cancers of high unmet need," said Dr. Sean McCarthy, chairman and CEO of CytomX Therapeutics.

"Additionally, this quarter, we were excited to announce a significant expansion of our Regeneron collaboration in bispecific immunotherapies, further validating our PROBODY therapeutic platform expertise. We are also pleased to be strengthening the CytomX team and board of directors for CytomX’s next phase of growth as we remain highly focused on making a meaningful difference for patients and stakeholders over the near- and long-term."

Pipeline Program Updates:

Varsetatug masetecan (EpCAM PROBODY Topo-1 ADC, CX-2051)

Varseta-M Monotherapy CRC:
Enrollment into the Varseta-M Phase 1 clinical study is complete with 113 total patients enrolled across the dose escalation, expansion, and optimization phases. As of the end of April 2026, enrollment in the dose optimization cohorts reached the goal of 40 patients across the 8.6 mg/kg Q3W and 10 mg/kg Q3W doses1.
A Phase 1 data update is expected by the end of 2026 with a focus on dose selection for late phase development.
FDA interactions are planned towards alignment on the first monotherapy Varseta-M registrational study in CRC which the company aims to initiate in the first half of 2027.

Varseta-M CRC Combinations:
A Phase 1 combination study of Varseta-M and bevacizumab is ongoing in late-line patients with an initial focus on the evaluation of safety, dose, and schedule for later phase development. Initial clinical data is anticipated in 1H 2027.
Additionally, a Phase 1/2 chemotherapy combination study including Varseta-M administered with bevacizumab, 5-fluorouracil, and leucovorin focused in 2nd line mCRC is planned to start in Q4 2026, supporting the goal of advancing Varseta-M into earlier lines of CRC treatment, potentially replacing chemotherapy in standard of care regimens.

Varseta-M Non-CRC Indication Expansion:
Varseta-M monotherapy Phase 1 expansion cohorts are initiating in Q3 2026 in gastric and gastroesophageal junction (GEJ), EpCAM selected pancreatic ductal adenocarcinoma (PDAC), and EpCAM selected biliary tract cancer (BTC), an initial step towards realizing Varseta-M’s pan-tumor potential as a multi-indication antibody drug conjugate.

CX-801 (PROBODY Interferon alpha-2b)

The CX-801 Phase 1 study in advanced melanoma is ongoing. The CX-801 monotherapy dose escalation portion of the study has reached the fourth dose level.
CX-801 monotherapy has been generally well tolerated at dose levels exceeding the approved dose of unmasked IFNα2b.2
In May 2025, Phase 1 dose escalation of CX-801 in combination with KEYTRUDA (pembrolizumab) was initiated. Dose escalation of CX-801 in combination with KEYTRUDA has cleared the third dose level and enrollment into the study continues.
Initial clinical data for CX-801 in combination with KEYTRUDA in advanced melanoma is expected in the first half of 2027.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

Corporate and Financial:

Strengthened Board of Directors and Leadership for Next Phase of Growth
Appointed Dr. Charles Fuchs, M.D., MPH, former Chief Medical Officer of Tubulis and former Senior Vice President and Global Head of oncology and hematology drug development at Genentech and Roche to the CytomX Board of Directors.
Expanded executive leadership team with the addition of Mamata G. Gokhale, Ph.D., RAC, as Senior Vice President of Regulatory Affairs and Alejandra V. Carvajal, J.D., as Senior Vice President, Chief Legal Officer & Secretary.
Regeneron Collaboration Expansion:
In June 2026, announced significant expansion of Regeneron collaboration building upon research momentum in developing next-generation bispecific immunotherapies using CytomX’s PROBODY and Regeneron’s Veloci-Bi platforms.
In July 2026, CytomX received $37.0 million target selection payment for two additional programs selected.
Regeneron also secured option to select up to 6 additional future targets bringing total potential target nomination, research, development, regulatory and sales-based milestones covered under the collaboration to up to approximately $4.0 billion.

Financial:
CytomX ended Q2 2026 with $330.3 million of cash, cash equivalents and investments with expected cash runway to at least the second half of 2028. The cash balance as of Q2 2026 does not include $37.0 million received in July 2026 as a result of the two targets selected by Regeneron as part of the expanded collaboration agreement.

Q2 2026 Financial Results:

Cash, cash equivalents and investments totaled $330.3 million as of June 30, 2026, compared to $346.7 million as of March 31, 2026.

Total revenue was $1.4 million for the quarter ended June 30, 2026, compared to $18.7 million for the second quarter of 2025. The decrease in revenue was driven primarily by the completion of the Company’s performance obligation during 2025 in the collaborations with Bristol Myers Squibb and lower research activities in the Astellas collaboration which concluded in the second quarter of 2026.

Total operating expense for the quarter ended June 30, 2026 was $25.2 million compared to $19.9 million for the quarter ended June 30, 2025, an increase of $5.3 million.

Research and development expenses increased by $4.3 million during the quarter ended June 30, 2026, to $17.6 million compared to $13.3 million for the quarter ended June 30, 2025. Research and development expenses increased primarily due to manufacturing activities for Varseta-M as well as increased personnel related costs and general research and development expenses.

General and administrative expenses increased by $1.0 million during the quarter ended June 30, 2026, to $7.6 million, compared to $6.6 million for the quarter ended June 30, 2025. Increased general and administrative expenses were primarily driven by higher consulting expenses and higher rent expenses.

(Press release, CytomX Therapeutics, AUG 6, 2026, View Source [SID1234669839])

BlossomHill Therapeutics Announces Pricing of Upsized $150 Million Initial Public Offering

On August 6, 2026 BlossomHill Therapeutics, Inc., ("BlossomHill Therapeutics"), a clinical-stage biopharmaceutical company applying an intentional, chemistry-based approach to develop innovative small molecule medicines for the treatment of cancer, reported the pricing of its upsized initial public offering of 9,375,000 shares of common stock at a price to the public of $16.00 per share. The gross proceeds to BlossomHill Therapeutics from the offering, before deducting underwriting discounts and commissions and offering expenses payable by BlossomHill Therapeutics, are expected to be $150.0 million, excluding any exercise of the underwriters’ option to purchase additional shares. In addition, BlossomHill Therapeutics has granted the underwriters a 30-day option to purchase up to an additional 1,406,250 shares of common stock at the public offering price, less underwriting discounts and commissions. All of the shares of common stock are being offered by BlossomHill Therapeutics.

The shares are expected to begin trading on The Nasdaq Global Select Market on August 7, 2026, under the ticker symbol "BLSM." The offering is expected to close on August 10, 2026, subject to the satisfaction of customary closing conditions.

J.P. Morgan, Leerink Partners and Guggenheim Securities are acting as lead book-running managers for the offering. LifeSci Capital and H.C. Wainwright & Co. are acting as joint book-running managers for the offering.

Registration statements relating to these securities have been filed with the U.S. Securities and Exchange Commission (SEC) and became effective on August 6, 2026. Copies of the registration statements can be accessed through the SEC’s website at www.sec.gov. This offering is being made only by means of a prospectus forming part of the registration statements relating to these securities. When available, copies of the final prospectus relating to the initial public offering may be obtained from: J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or by email at [email protected] and [email protected]; Leerink Partners LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, by telephone at (800) 808-7525 ext. 6105 or by email at [email protected]; or Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Ave., 8th Floor, New York, NY 10017, by telephone at (212) 518-9544, or by email at [email protected].

This press release does not constitute an offer to sell, or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction. Any offers, solicitations or offers to buy, or any sales of securities will be made in accordance with the registration requirements of the Securities Act of 1933, as amended.

(Press release, BlossomHill Therapeutics, AUG 6, 2026, View Source [SID1234669838])

OmniAb Reports Second Quarter 2026 Financial Results and Business Highlights

On August 6, 2026 OmniAb, Inc. (NASDAQ: OABI), a provider of cutting-edge discovery research technology to enable the discovery of next-generation therapeutics, reported financial results for the three and six months ended June 30, 2026, provided operating and partner program progress, and updated 2026 financial guidance.

"We are pleased to report a strong quarter and to increase our revenue and cash outlook for 2026 based on continued momentum in our business. Recent updates from partner programs have been very encouraging with important advancements in clinical development," stated Matt Foehr, Chief Executive Officer of OmniAb. "We continue to efficiently leverage and expand the reach of our core and highly differentiated discovery technologies, as we also focus on our promising xPloration platform. We recently expanded our executive leadership with the addition of Chief Operating Officer Amechi Nwachuku, who has quickly integrated into our team to drive and strengthen this area. We believe we’re well positioned to accelerate growth, and we look forward to providing business updates and technology highlights and plans at our October Investor and Analyst Day."

Second Quarter 2026 Financial Results

Revenue for the second quarter of 2026 was $13.4 million, compared with $3.9 million in the prior-year period, with the increase driven primarily by milestone revenue. Service revenue increased primarily due to the commencement of new ion channel programs, and xPloration revenue increased on higher instrument sales and related consumables.

Cost of xPloration revenue was $0.6 million for the second quarter of 2026, compared with $0.3 million for the same period in 2025. The increase was due to increased instrument and consumable sales. Research and development expense was $9.6 million for the second quarter of 2026, compared with $10.9 million for the same period in 2025, with the decrease due to lower personnel expense related to share-based compensation and salary expense and lower facility-related costs. General and administrative expense was $6.7 million for the second quarter of 2026, compared with $7.7 million for the same period in 2025, with the decrease primarily due to lower personnel expense related to share-based compensation and salary expense and lower professional fees.

Amortization of intangibles decreased to $3.1 million for the second quarter of 2026, compared with $3.2 million for the same period in 2025. Other operating expense (income) increased to $0.2 million for the second quarter of 2026 from ($1.9) million for the same period in 2025, primarily as a result of a net $2.0 million one-time gain from the sale of a small-molecule program in the second quarter of 2025.

Total costs and operating expenses were $20.1 million for the second quarter of 2026, flat with $20.1 million for the same period in 2025.

Cash costs and operating expenses were $13.3 million for the second quarter of 2026, compared with $11.9 million for the same period in 2025 (see note regarding "Use of Non-GAAP Financial Measure" below for further discussion of this non-GAAP measure).

Net loss for the second quarter of 2026 was $5.9 million, or $0.05 per share, compared with a net loss of $15.9 million, or $0.15 per share, for the same period in 2025.

Year-to-Date Financial Results

Revenue for the first half of 2026 was $27.8 million, compared with $8.1 million for the same period in 2025, with the increase primarily related to milestone revenue. Service revenue increased primarily due to the commencement of new ion channel programs, and xPloration revenue increased on higher instrument sales and related consumables.

Cost of xPloration revenue was $0.6 million for the first half of 2026, compared with $0.3 million for the same period in 2025. The increase was due to increased instrument and consumable sales. Research and development expense was $19.2 million for the first half of 2026, compared with $23.5 million for the same period in 2025, with the decrease due to lower personnel expense related to share-based compensation and salary expense, lower external expenses associated with legacy small-molecule ion channel programs and lower facility-related costs. General and administrative expense was $13.3 million for the first half of 2026, compared with $15.6 million for the same period in 2025, with the decrease primarily due to lower personnel expense related to share-based compensation and salary expense and lower professional fees.

Amortization of intangibles increased to $9.1 million for the first half of 2026, compared with $6.5 million for the same period in 2025, primarily due to a $2.9 million non-cash impairment related to the discontinuation of certain legacy small-molecule ion channel programs recorded in the first quarter of 2026.

Other operating expense (income) for the first half of 2026 was $0.1 million compared to ($2.7) million for the same period in 2025. The prior-year period included a net $2.0 million one-time gain from the sale of a small-molecule program in the second quarter of 2025.

Total costs and operating expenses were $42.3 million for the first half of 2026, compared with $43.1 million for the same period in 2025.

Cash costs and operating expenses were $25.5 million for the first half of 2026, compared with $26.6 million for the same period in 2025 (see note regarding "Use of Non-GAAP Financial Measure" below for further discussion of this non-GAAP measure).

Net loss for the first half of 2026 was $13.6 million, or $0.11 per share, compared with a net loss of $34.1 million, or $0.32 per share, for the same period in 2025.

As of June 30, 2026, OmniAb had cash, cash equivalents and short-term investments of $52.0 million.

2026 Financial Guidance

OmniAb revises 2026 financial guidance and now expects revenue to be in the range of $32 million to $36 million, versus $28 million to $33 million previously, and costs and operating expenses to be in the range of $84 million to $88 million, versus $83 million to $88 million previously. Cash costs and operating expenses are expected to be in the range of $51 million to $55 million, versus $50 million to $55 million previously (see note regarding "Use of Non-GAAP Financial Measure" below for further discussion of this non-GAAP measure). The Company now expects to end the year with cash and cash equivalents in the range of $37 million to $41 million, versus $33 million to $38 million previously. The full-year 2026 effective tax rate is expected to be approximately 0%.

Second Quarter 2026 and Recent Business Highlights

During the second quarter of 2026, OmniAb entered into new license agreements with EnRosa Therapeutics and argenx. As of June 30, 2026, the Company had 110 active partners and 425 active programs, including 34 OmniAb-derived programs in clinical development or being commercialized.

Business and partner highlights from the second quarter of 2026 and recent weeks included the following:

JNJ-5322

Ramantamig (JNJ-79635322), a tri-specific antibody targeting (BCMA x GPRC5D x CD3), has advanced to Phase 3 from Phase 1 clinical trials. The Phase 3 study is randomized study comparing JNJ-79635322 and an anti-BCMAxCD3 bispecific antibody in participants with relapsed or refractory multiple myeloma who have received at least three prior lines of therapy including a PI, an IMiD, and an anti CD38 antibody.
Precemtabart tocentecan (M9140)

Merck KGaA, announced the first patient has been dosed in the Phase 3 PROCEADE-CRC-03 trial evaluating precemtabart tocentecan, a potential first‑in‑class investigational anti‑CEACAM5 antibody‑drug conjugate (ADC), for the treatment of metastatic colorectal cancer based on Phase 1 data.
The Phase 3 study will assess the efficacy and safety of precemtabart tocentecan, alone or with bevacizumab, in patients with metastatic colorectal cancer who are intolerant- or refractory-to, or progressed after, systemic therapies.
Phase 1 data from the PROCEADE-CRC-01 study showed predictable and manageable safety in more than 100 patients with heavily pretreated metastatic colorectal cancer. At the recommended dose for Phase 3 development (2.8 mg/kg Q3W; n=29), confirmed objective response rate was 20.7% (95% CI: 8.0, 39.7), median PFS was 6.9 months (95% CI: 4.4, 9.5), and median OS was not reached after a median follow-up of 13.1 months (95% CI: 8.7, NE).
TEV- ‘408

Teva Pharmaceuticals announced plans for its TEV-’408, an investigational anti-interleukin-15 monoclonal antibody, to advance into a Phase 2b study in vitiligo in the fourth quarter of 2026 following encouraging results from an ongoing Phase 1b, open-label study in adults with active or stable non-segmental vitiligo (NSV).
Topline results in Phase 1b trial evaluating TEV-‘408 for vitiligo showed improvements in skin pigmentation in patients with active or stable NSV. TEV-’408 was well-tolerated with no safety signals observed. At baseline, 66% of enrolled participants had vitiligo affecting more than 10% of body surface area, representing a population with limited treatment options. At week 24, in evaluable participants, nearly 75% of patients reported improvement in facial vitiligo, with half reporting "much" or "very much" improved, 42% achieved F-VASI50 and 21% achieved F-VASI75, 55% of patients reported improvement in total body vitiligo, and 7% achieved T-VASI50.
Teva Pharmaceuticals and Royalty Pharma entered into a funding agreement of up to $500 million to accelerate the clinical development of TEV-‘408 for vitiligo.
Topline results of the Phase 2a trial evaluating TEV-‘408 for celiac disease continue to be expected in the second half of 2026.
IMVT-1402

Immunovant announced preliminary week 16 IMVT-1402 results in the difficult-to-treat rheumatoid arthritis trial that showed clinically meaningful response rates of 72.7% ACR20, 54.5% ACR50 and 35.8% ACR70.
Immunovant’s development plans for IMVT-1402 remain on track across all six announced indications. They expect to provide further updates on the potentially registrational IMVT-1402 difficult-to-treat rheumatoid arthritis program and report topline data from the proof-of-concept trial of IMVT-1402 in cutaneous lupus erythematosus in the second half of calendar year 2026. In calendar year 2027, topline data are anticipated for the potentially registrational trials evaluating IMVT-1402 in Graves’ disease and myasthenia gravis. Topline data are expected to follow in calendar year 2028 for the potentially registrational trials of IMVT-1402 in chronic inflammatory demyelinating polyneuropathy and Sjögren’s disease.
BI 3802876

Boehringer Ingelheim has commenced its Phase 2a double-blind, placebo-controlled study evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of BI 3802876 in participants with compensated cirrhosis due to metabolic dysfunction-associated steatohepatitis (MASH). The study is to evaluate BI 3802876 tolerance and dose response in MASH patients.
Sugemalimab

Arrotex Pharmaceuticals entered into an exclusive commercialization agreement with CStone Pharmaceuticals for Sugemalimab, a fully human anti–PD-L1 monoclonal antibody, covering all approved and future indications in Australia and New Zealand. The agreement includes potential commercialization across stage III and IV non-small cell lung cancer, gastric cancer, esophageal squamous cell carcinoma, and extranodal NK/T-cell lymphoma, subject to regulatory approval by Australia’s Therapeutic Goods Administration.
VXA-222

VERAXA Biotech announced the advancement of bispecific ADC (bsADC) program VXA-222, following successful achievement of a key technical milestone in its alliance with OmniAb. The program is moving into its next collaboration phase with OmniAb’s discovery work successfully concluded. VXA-222 utilizes an "AND-gate" logic to address two different target antigens present on solid tumors with one molecule.
Additional Updates

The company appointed Amechi Nwachuku to the newly-created position of Executive Vice President and Chief Operating Officer, primarily responsible for managing the strategy, operations and commercial maximization of xPloration.
OmniAb will host an Investor and Analyst Day on October 6, 2026 at its corporate headquarters in Emeryville, CA. The agenda for the day will include presentations by management, panel discussions, and a lab tour for those attending in-person. For additional information and participation details, please visit.
Conference Call and Webcast

OmniAb management will host a conference call with accompanying slides today beginning at 4:30 p.m. ET (1:30 p.m. PT) to discuss this announcement and answer questions. To participate via telephone, please dial (833) 461-5787 using the conference ID 545137839. Slides, as well as the live and replay webcast, are available here.

(Press release, OmniAb, AUG 6, 2026, View Source [SID1234669837])

Dispatch Bio Announces First Patient Dosed in Phase 1 Study of DISP-10, a Novel Investigational Immunotherapy, in Advanced Gastrointestinal (GI) Cancers

On August 6, 2026 Dispatch Bio, a biotech company engineering a universal treatment across solid tumors leveraging its first-in-class Flare platform, reported the first participant has been dosed in a Phase 1 clinical trial evaluating the safety and efficacy of DISP-10 in adult participants with advanced gastrointestinal (GI) cancers, including colorectal cancer, gastric adenocarcinoma, esophageal adenocarcinoma, and gastroesophageal adenocarcinoma. The participant was treated with both DV-10 and ide-cel components of DISP-10 and completed the protocol-defined dose-limiting toxicity (DLT) evaluation period. Additionally, DISP-10 has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for the treatment of advanced GI cancers. DISP-10 is a novel, investigational therapy designed to address key challenges in the treatment of solid tumors.

"Initiating this trial represents a meaningful step forward for patients with advanced GI cancers, reinforced by the FDA’s Fast Track designation for DISP-10," said Mauro Avanzi, M.D., Ph.D., Chief Medical Officer of Dispatch. "We look forward to advancing this study as we work to overcome the longstanding limitations of treating solid tumors with immunotherapy, including lack of a safe and homogeneously expressed target antigen, a narrow therapeutic window, and an inhibitory tumor microenvironment. DISP-10 aims to address these barriers with our novel approach."

DISP-10 consists of two components. The first component, DV-10, is a tumor-specific virus engineered to deliver a modified B cell maturation antigen (dBCMA), along with IL-18 and CXCL9, to "paint" a synthetic antigen onto tumor cells, remodel the tumor microenvironment to support T cell function, and help enhance T cell trafficking into tumors. The second component is ide-cel, Bristol Myers Squibb’s BCMA-directed CAR T cell therapy approved in the U.S.* By leveraging components with significant clinical experience, Dispatch aims to proceed rapidly through clinical development and ultimately bring a major advancement and option to patients suffering from advanced GI cancers, including colorectal cancer, which currently is the leading cause of cancer death among people under age 50.1

"Patients with advanced GI cancers can face a challenging prognosis, often measured in a handful of months with limited treatment options beyond chemotherapy," said Marwan Fakih, M.D., Division Chief, GI Medical Oncology and Deputy Director, City of Hope Comprehensive Cancer Center. "There is a clear need for new approaches, and the initiation of this study with DISP-10 is an important step toward exploring a novel strategy that may expand the reach of immunotherapy treatments for patients."

The first-in-human, Phase 1, multicenter, open-label clinical study is designed to evaluate the safety, tolerability, and activity of DISP-10. The FDA’s Fast Track designation is intended to accelerate the development and review of investigational therapies that have demonstrated their potential to address serious conditions with unmet medical need. The designation enables more frequent engagement with the FDA and may allow for rolling review and other mechanisms to expedite the regulatory process.

*Ide-cel has not been studied and is not approved for use in solid tumors.

(Press release, Dispatch Bio, AUG 6, 2026, View Source [SID1234669836])